# K192887: Revitive Medic Plus, Revitive Advanced 2

- Pathway: 510(k) (Traditional)
- Applicant: Actegy, Ltd.
- Decided: May 4, 2020 after 207 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
NMES: - To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance. - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - For relaxation of muscle spasm, - Increase of blood flow circulation, - Prevention or retardation of disuse atrophy, - Muscle re-education, - Maintaining or increasing range of motion, - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - For users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping TENS: - For symptomatic relief and management of chronic intractable pain - Relief of pain associated with arthritis - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities

Source page: https://510kreport.com/device/K192887
Methodology: https://510kreport.com/methodology